Syva® Viva-ProE™ System PEP To Go

SIEMENS Distributed by Siemens Viva-prot Syva® Viva-ProE™ System PEP To Go www.siemens.com/diagnostics Answers for life. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. HILS#705 Effective date 06/01/2016 © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Table of Contents 1. Hardware Overview 2. Status Icons 3. Start of Day / Daily Maintenance 4. Request and Run Calibration 5. Evaluate QC 6. Request and Run Samples 7. Unload Samples 8. End of Day Procedures 9. Weekly Maintenance 10.Monthly Maintenance 11.Quarterly Maintenance 12.Semi-Annual Maintenance Syste 13.As-Needed Maintenance Viva-PI 14.Backing Up 15.Troubleshooting © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Table of Contents © Siemens AG 2013. All rights reserved. Hardware Overview External Hardware Overview 1. Computer and Touchscreen 2. Keyboard 3. Glass Safety Cover 3 1 4. Cabinet for Treated Water and Diluted Waste 5. Cabinet for Concentrated Waste 6. Cabinet for Reagent and Sample Pipettors 6 5 4 Distributed by Siemens Viva-ProE 2 © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Hardware Overview © Siemens AG 2013. All rights reserved. Hardware Overview Internal Hardware Overview 1. Reagent Rotor: holds the reagent bottles 2. Cuvette Rotor: contains 48 cuvettes. Location where reagents and samples are added and mixed and where the measurement takes place 4 5 3. Sample Rotor: holds the sample tubes 2 4. Reagent Probe: aspirate and 1 3 dispense reagents O 5. Sample Probe: aspirate and dispense samples © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Status Icons Unable to perform test; select Details for more information Control / Calibrator loaded; request to change test cannot be made at this time Reagent / Calibration / Control Expired Reagent / Control Expiration date Extended Reagent Level Low Reagent Level Empty i Select for information Select for Task Select to Stop System Status Alert © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Status Icons © Siemens AG 2013. All rights reserved. Start of Day / Daily Maintenance On the Home screen select Start of Day Start of Day 1. Empty diluted and concentrated waste containers following standard laboratory operating procedures 2. Fill treated water container Start of Day  Check for sufficient amount of water in treated water container to run samples. If needed, fill an empty 5 L water Description Status container with distilled or deionized water. Add 12.5 mL of 1 Empty Waste System Solution 3. Check syringes during Prime System 2 Fill treated water container  From the Home screen, select Tasks > Maintenance > 3 Prime and Drain > Prime System Check syringes  Verify no air bubbles or leaks are present 4 Check cuvette blank  Remove caps off reagent bottles in the reagent rotor Check/refill 10% cleaning solution 4. Check cuvette blank  If the cuvette blank results are within the defined acceptable 6 Check daily report ranges, the measurement is automatically accepted and the information on the screen updated. No further action is 7 Check 0. 1N HCI Cleaning Solution required. 8 Check Reagent Inventory  If the cuvette blank results are not within the defined 9 acceptable ranges, refer to the Troubleshooting section of Remove Caps this guide for details 5. Check / refill 10% cleaning solution (Probe rinse)  Fill the tube located in the wash on the sample rotor with Note: The minimum Start of Day tasks include 1 cleaning solution through 6 shown above. This checklist can be edited when logged into the system as an Administrator.  If the cleaning solution has expired, select Check/refill 10% cleaning solution, then select Replace > enter Lot Number, Expiration Date > Accept © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Start of Day / Daily © Siemens AG 2013. All rights reserved. Maintenance Start of Day / Daily Maintenance Reagents admin 4/29/2014 8:46:02 AM Print Help 6. Check daily report Filter by Test Clear 8 Reagent Info  Select tabs to view expired or expiring Pos Tests Reagent Status Load Standar R4 T50 Unload Switch Rotor calibrator/control lots, reagents and calibrator and R5 CR R6 6 AM Replace 7 2 2 2 control planning R7 R3 R8  Select maintenance planning to view tasks that are R9 R10 required R11 R17 R2 R12 Probe rinse  Select Daily Report to print a copy of the report R13 Acid Solution 7 R14 7. Check 0.1N HCl Cleaning Solution (Acid Solution) R15 R16 R17  Fill the bottle located in the reagent rotor C15 R2 R18 OP3 R2 R19 T50 R2  If the cleaning solution has expired, from the R20 CR R2 R13 R21 BAM R12 Reagents screen, select Replace, enter Lot Number, R22 Expiration Date, and select Accept QC 8. Check Reagent Inventory Stop Home Reagents Calibration Central Patients Sean Results Unload OC Events  Select the Reagents icon Reagents admin ?  Select Reagent Info 4/29/2014 8:43:50 AM Logout Print Help Filter by Test Clear  If reagent is flagged (see Status Icons), the bottle 8 Print Hide Info POS Tests Reagent Status Lot Number Lot Expiration requires refill 2 5 Onboard Stability Remaining Volume Remaining Tests Completed Tests CR 7/31/2014 10.9 mL 38 R6 6AM R1 F4A 11/30/2014 9d 12.5 ml 68 12  Under Remaining Tests column, view test number R7 RB R9 if less than 10, fill the bottle R10 –  On the Reagents screen, select the bottle to refill, R11 R12 Probe rins 1007 7/23/2014 28.0 ml 16.9 mL select Replace, enter Lot Number, Expiration Date, R13 Acid Solution 45158 5/3/2015 R14 R15 and select Accept R16 AMS 7/31/2014 10.3 ml R17 C15 R2 F4A 8/30/2014 10 8.7 ml 103 Note: If the lot # of the reagent has changed, R18 OP 3 R2 F3 11/30/2014 5h 3.8 mL 47 31 R19 T50 R2 E8 7/31/2014 5h 4.7 ml 54 calibration is required to be performed R20 CR R2 F1 GAM FAA 7/31/2014 5h 5.6 mL 97 R21 11/30/2014 0.0 ml 9. Remove Caps off reagent bottles R22 R23 R24 Qc Stop Home Reagents Calibration Central Patients Scan Results Unload OC Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Start of Day / Daily Maintenance Request and Run Controls From the Home screen select Control Control Load Controls admin 1 4/11/2014 8:22:46 AM Logout Print Help 1. Select Load for each control Control Tests Control Lot Pos 37 Level 0 (Negative) AM5 6AM C15 OP3 T50 A1 Unload 2. Load the controls into their assigned positions Level 5 (Positive) AM5 C15 OP3 T50 F5 AZ Level 4 (6-AM) 6AM F A3 A10 on the sample rotor UTAK Validity 3 CR A1035 AA 32 A11 UTAK Validity 4 CR A1036 A5 3. Lower glass lid, select Process > Yes 49 A12 Process A7 28 W 27 26 4. If internal barcode scanner is on, select Scan 2 25 prior to process A6 23 Scan 20 21 Note: Level 0 (Negative) and Level 5 (Positive) 19 12 controls are run daily to validate the existing qualitative DAT calibration curve. 3 Review UTAK controls are run daily to validate the validity QC calibration curve. Stop Home Reagents Calibration Control Patients Results Unload ac Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Start of Day / Daily Maintenance Evaluating Qualitative DAT & Validity Controls 1. On the Results screen select the Calibrators Result and Controls radio button 1 admin 4/2/2014 10:53:59 AM Logout Print Help Reagent Blanks Calibration and Controls Patients Search 2. Select the test to display the measurement results Test Amphetamines 500 - Emit Cal Level 2 Amphetamines 500 - Control 3. Verify the Level 0 result as negative and Level 5 result 4 AM5 2 Level Value dAbs/m Flags Control Result Range as positive 6AM Level 2 500.0000 0.3961 Level 0 3 (Negative) Negative 0.34580 4. Results automatically accept if there are no flags C15 Level 5 (Positive) Positive 0:54211 V except for v and V OP3 lowercase v indicates negative T50 Details Details uppercase V indicates positive CR 0.3961 5. If the result is flagged, select from the following 0.3169 0.2377 options: 0.1585 Select Repeat to rerun the control measurement 0.0792 .. ...... 0.0000 Absorbance (dAbs/min) Select Accept to accept the control measurement 50 0 50 100 150 200 250 300 350 400 450 500 550 Concentration result A Status: Accepted 4/2/2014 10:27 AM Select Reject to reject the control measurement Export Print Daily QC Accept -Curve Reject Curve result O QC Note: If Repeat is selected, the Viva-ProE™ system will Stop Home Reagents Calibration Control Patients Resume Results Unload Qc Events average the results of both replicates. Siemens recommends selecting Reject, and then rerun the control Note: The system will not run test(s) requests in which the control(s) are flagged unacceptable or out of range. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Request and Run Calibration Request Calibration admin ? 6/3/2014 1:26:30 PM Logout Print Help Details 4 Summary Calibration Reagent Blank AM5 6AM C15 OP3 1. Print the previous stored calibration to use to compare 150 CR to the new calibration:  From the Home screen, select the following: Results > Calibration and Controls > select the individual test > Print 2. On the Home screen select Calibration Calibration 3. Select Review to open Request Calibration screen 5 4. Select the desired test or tests that require calibrating Close Accept Cancel 5. Select Accept QC 6. On the Load Calibration screen, select Load for each Stop leagents Calibration Patibeds oc Events calibrator and load the calibrators into the assigned Load Calibration 6 admin ? 3/21/2014 9:01:07 AM Logout Print Help positions on the sample rotor Calibrator Tests Calibrator Lot Level Pos Load DAT CAL Level 2 +AM5 +COC F3 Level 2 Unload 7. At the bottom of the screen, select the Control icon 12/30/2014 Control Select Load for each control and load the controls into DAT CAL Level 1 +OP3 F3 8. 12/30/2014 Level 1 DATCAL Level 3 F4 47 the assigned positions on the sample rotor +T50 12/30/2014 Level 3 9. Lower glass lid and select Process > Yes Creatinine Validity CR E2 or 2 12/30/2014 Calibrat or 20 10. If the internal barcode scanner is on, select Scan prior to Process 11. When the exclamation point is visible on the Results icon, the calibration is ready for evaluating 7 9 Revier 13 QC Stop Home Reagent callitation Central Patients Process Results Unload QC Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Request and Run Calibration Request and Run Calibration Evaluating Qualitative DAT & Validity Calibration On the Home screen select Results icon Results 1 admin 4/2/2014 10:53:59 AM Logout Print Help 1. On the results screen, Calibrators and Controls Reagent Blanks Calibration and Controls Patients Search radio button should be selected Test Amphetamines 500 - Emit Cal Level 2 Amphetamines 500 - Controls 2. Select the test to display the measurement results AM5 Level Value dAbs/m Flags Control Result Range Flags 3. Evaluate the dAbs/m result to the previously stored 6AM 2 Level 2 500.0000 0.3961 Level 0 (Negative) Negative 0.34580 V dAbs/m result printout C15 Level 5 (Positive) Positive 0.54211 V  The new result should be relatively OP3 comparable to the previous result T50 6 Details Details CR 4. *Select Accept Curve if acceptable 0.3961 13 15 15 15 0. 3169 5. Select Reject Curve if unacceptable 0.2377 0.1585 ............ ....... 6. If results are flagged, select Details to view 0.0792 ............................ additional information 0.0000 Absorbance (dAbs/min) -50 0 50 100 150 200 250 300 350 400 450 500 550 Concentration *Note: Level 0 (Negative) and Level 5 (Positive) Status: Accepted 4/2/2014 10:27 AM 4 5 A controls are run daily to validate the stored calibration Export Print Daily Q Accept-Curve Reject Curve curve for Qualitative DAT UTAK controls are run daily to validate the stored QC Stop Home Reagents Calibration Control Patients Resume calibration curve for Validity tests Results Unload DC Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Evaluating QC Qc admin 12 4/11/2014 3:15:13 PM On the Home screen select the QC icon QC 2 -- - 1 Controis Tests Graph Table Control Level 0 (Negative) . Amphetamines 500 Level 0 (Negative) AMS Level O (Negative) QC Rules: Separation: Average Average 0 05666 SD 0,00406 CV 72% N 7 Lot F3 4 Stability 17 d Unit: Expected Separation: 0.01500 Expiration 80d Amphetamines 500 1. Select the Controls radio button to display QC 6Acetyl Morphine 10 Cocaine 150 controls Opiates 300 THC 50 OR Level 4 (6 AM) Level 5 (Positive) 2. Select the Tests radio button to display QC tests UTAK Validity 3 UTAK Validity 4 3. Select the control or test to view the measurement history 0.02 4. Select the white triangle to view the tests or @ 10 18 22 26 30 34 38 42 46 50 54 58 09 50 62 66 70 74 78 82 86 90 6 Value Overrange 7 Underrange X Rule violation * Excluded O Override - Tatpet controls 4/11/2014 8 45:06 AM Value 0.05250 Comment Exclude 5. Select the control or test OC 6. To exclude an individual point: Stop Raagents Calbeison Control Patent OC  select the point  select Exclude Qc 7 admin  enter a comment in the box 4/4/2014 9:15:07 AM Logout Print Help Controls Tests Graph Table Note: Excluded QC point changes to an asterisk * Control Level 0 (Negative) - Amphetamines 500 Level 0 (Negative) Level 0 (Negative) QC Rules: Separation: Average 0.04830 SD 0.00170 CV Lot F3 Stability 25 g Unit: Expected Separation: 0.01900 Expiration 87 d Amphetamines 500 7. To view in table format, select Table tab 6Acetyl Morphine 10 Date Time Target Value Commen Cocaine 150 4/4/2014 8:38 AM 0 04856 Opiates 300 4/3/2014 8:33 AM 0.04600 THC 50 4/2/2014 10:50 AM 0.05034 Level 4 (6-AM) Level 5 (Positive) UTAK Validity 3 UTAK Validity 4 Note: The QC screen displays the statistical and graphical information of control measurements and can be viewed in a Graph or Table format V Reset Westgard Override Rules Comment Exclude Qc Stop Home Reagents Calibration Control Patients Results Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Evaluating QC © Siemens AG 2013. All rights reserved. Request and Run Samples Load Patients 2 8 admin 4/4/2014 9:39:14 AM Logout Print Help Process Non Barcoded Sample Test Requests on earch ID 1 Create Load Unload the System Sample ID 1234 Position 1 Edit 33 Comment Delete 31 On the Home screen select Patients ID Patient Name Tests Pos 47 1234 Nancy Jones AM5 C15 OP3 T50 CR 1. In the Load Patients screen, enter the ID into the 1 1235 Jack Philips AM5 C15 OP3 T50 CR 49 48 8 28 Search ID test box 1236 Mary Myers AM5 C15 OP3 T50 CR 50 W 1237 Ko Kane AM5 C15 OP3 T50 CR 2. Select Create to open the Request Patient’s screen 1238 Sam Sha AM5 C15 OP3 T50 CR 5 23 The Request Patient screen will open. 20 3. Select Request Type – Routine, ASAP or STAT A3 16 (default is Routine) 9 17 13 15 4. Enter the Patient Data as required by your Print List laboratory O QC Stop Home Reagents Calibration Control Patients Process Results Unload Events 5. Select the Sample Type from the drop down menu OC 6. Select a panel or individual tests Request Patient 6 admin 4/4/2014 9:32:50 AM Logout Print Help Sample ID 1234 Position Tests 7. Select Accept 3 Request Type Routine ASAP STAT AM5 6AM C15 OP3 T50 MR# 4 CR Name Nancy Jones In the Load Patients screen: Physician 8. Select Load for each sample and place them into 5 Birth Date Midiyyyy Replicates Sample Type Urine Collection Date M/d/yyyy the assigned position on the sample rotor Sex Male Female Pediatric 9. Close the glass cover and select Process Category None Comment and Yes Panels ALL TESTS 7 Repeat Programming Mode Accept Cancel O Qc Stop © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Results Request and Run © Siemens AG 2013. All rights reserved. Samples Request and Run Samples Evaluating Sample Results On the Home screen select Results Result Results 1 admin 4/29/2014 1:58:43 PM Logout Print Help 1. Select the Patients radio button to open the Reagent Blanks Calibration and Controls Patients O Search Patient view Loaded Recent Sample details 2. Select the desired sample to view the sample ID Name Status MR# Sex Female Sample ID 1234 Request Type Routine 1234 4/29/2014 details Nancy Jones 2 Patient Name Nancy Jones Sample Type Urine 11:31 AM Birth Date Sent to LIS No  If there are no flags on a test result, the 1235 Jack Phillips 4/29/2014 Physician Status Complete 11:34 AM Collection Date result is automatically accepted by the 1236 Mary Myers 4/29/2014 Completion 4/29/2014 11:31 AM system software 11:29 AM Comment 1237 Ko Kane 4/29/2014 3. To view the details of a specific test, select the 11:36 AM Test Name Value Flags 1238 Sam Sha 4/29/2014 AMS Negative 0.3511 v white triangle and measurement to view 11:38 AM detailed information 3 C15 Negative 0.2693 v OP3 Positive 0.3124 V Measurement 0.3124 dAbs/m 4. Select: T50 Negative 0.2545 v  Print to print the test results CR 28.0 mg/dl  Summary Report to print a summary Options 4 Mew Test View Calibration View Blank report which contains result details for 5 Print multiple patients Summary Report Ranund to LIS Export Repeat Accon Reject Cancol Test  Export to create a CSV file QC  Resend to LIS resend test result to LIS Stop Home Reagents Calibration Control Patients Scan Results Unload Qc Events 5. Select :  Repeat to repeat the test  Accept or Reject to reject flagged results © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Unload Samples / Calibrators / Controls From the Home screen, select Unload Unload admin 4/4/2014 9:10:50 AM Logout Print Help Unload Type Name Sample ID / Level Pos Unload All 2 Control Level 0 (Negative) A Unload 1. Select the completed sample, Control Level 5 (Positive) AZ 33 Control UTAK Validity 3 1 A3 A10 calibrator, or control from the rotor or A9 Control UTAK Validity 4 A4 47 the unload list 46 49 48 A12 28 2. Select Unload or Unload All to 50 W 27 remove all completed calibrators, 26 controls or samples from the rotor 25 A6 24 1 22 23 3. Physically remove the samples, 45 20 calibrators, or controls from the 18 sample rotor 6 19 15 DC Stop Home Reagents Calibration Control Patients Results Unload QC Events © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Unload Samples End of Day Procedures 1. Verify all measurements are completed. End of Day admin 6/27/2014 9:38:06 PM Logout Print Help Description Status Check/empty waste 2. Unload all completed samples. 2 Check/refill treated water container 3 Cap Reagent Bottes Remove samples from instrument/software 3. From the Home screen, select the End of Day icon. The screen displays a list of tasks that must be performed at the end of each day. End of Day 4. Perform all tasks that show an orange flag or exclamation mark. EG QC Stop Home Reagents Calibration Control Patients Process Results Unload Qc Events 5. Select the checkbox next to the task to mark as complete. Note: The minimum End of Day tasks include Check/empty waste and Check/refill treated water container. This checklist can be edited when logged into the system as an Administrator. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. End of Day © Siemens AG 2013. All rights reserved. Procedures Weekly Maintenance Rinsing the Probes 1. Fill the 10% cleaning solution bottle on the reagent rotor and the tube in the W position on the sample rotor, with fresh 10% cleaning solution 2. On the Home screen, select the Tasks icon 3. Select Maintenance > Clean Cuvette/Rinse Probe > Probe Rinse Note: This process may take up to 5 minutes to complete © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Weekly Maintenance Monthly Maintenance Clean Waste and Treated Water Containers From the Home screen select the Tasks icon 1. Select Maintenance > Clean Waste and Treated Water Container 2. Empty the treated water container ED 3. Pour 0.1N NaOH (Sodium Hydroxide) to coat the bottom of the Treated Water container DILUTED WASTE 4. Shake the container to distribute the NaOH 5. Pour the NaOH from the Treated Water container into the empty Diluted Waste container and repeat steps 3 and 4 6. Pour the contents into the empty Concentrated Waste container and repeat steps 3 and 4 7. Rinse the Treated Water container only with distilled water three times to remove the NaOH 8. In the Maintenance screen, select Confirm 9. Select Reset > Yes to reset the system and return to a stand-by state (1) Rese © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Monthly Maintenance Quarterly Maintenance Replace the Drying Block From the Home screen select the Tasks icon 1. Select the Maintenance tab 2. Remove the cuvette rotor cover 6 3. Select Replace Drying Block on the left side of the 2 screen 4. Select again Replace Drying Block on the right side 5 of the screen 5. Disconnect the tubing [2] from the front end of the drying block and move aside 6. Loosen the Block Screw [1] and lift off the Block [6] over the drying block (screw can remain inside the Block) 7. Remove the Drying Block [3] by pulling it up and to the right. Replace with a new one 4 3 8. Reinstall the Block [6] with the block screw but do not tighten the screw OYD 9. Select Continue in the software 10.Tighten the screw and reattach the tubing [2] to the drying block 11.Select Continue in the software 12.Select the Reset icon to reset the system and return to a stand-by state 13.Replace the cuvette rotor cover © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Quarterly © Siemens AG 2013. All rights reserved. Maintenance Semi-Annual Maintenance Replace the Stirrer Belt From the Home screen select the Tasks icon 1 1. Select Maintenance > Replace Stirrer Belt 2 2. Remove cuvette rotor cover W 3. Remove stirrer belt [2] from the pulley [1] HAA 0 210 0 4. Starting from the eccentric pulley [3], place the new stirrer belt around the pulley 5. Repeat steps [3] and [4] for the second pulley 6. In the software, select Confirm 7. Select the Reset icon to reset the system and return to a stand-by state Note: A pair of tweezers is useful when performing this task © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Semi-Annual Maintenance Semi-Annual Maintenance Replace the Water Filter From the Home screen select the Tasks icon 1. Select Maintenance > Replace Water Filter 2. Remove the Treated Water Container from inside the cabinet 3. Remove the Treated Water Container cap [1] 4. At the end of the tubing [3], remove the water filter [5] by unscrewing from the filter holder [4] Note: To avoid contamination of the water, do not lay the tubing with the filter on an unclean surface W TREATED WATER 5. Replace with a new filter by screwing back on the filter holder 6. Place the tubing with filter back inside of the Water Container and secure the cap 7. Place the Water Container back inside the cabinet 5 8. In the software, select Confirm 9. Select the Reset icon to reset the system and return to a stand-by state © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Semi-Annual Maintenance cap Clean the System From the Home screen select the Tasks icon 1. Select Maintenance > Clean System 2. Empty the Diluted Waste container 3. Remove the cap and tubing with the attached filter from the Treated Water container tubing 4. In the software, select Clean System – the system will cycle for approximately 30 minutes while it flushes TREATED all of the fluid from the instrument Note: Operator assistance is required during this entire procedure. The system software will prompt the operator to perform a task and wait for confirmation after each step. This procedure can take up to 4 hours to complete. 5. Fill a container with approximately 500 mL of Sodium Hypochlorite System Cleaning Solution. Be sure to use a container that will allow the filter from the Treated Water tubing to be completely submerged in the system cleaning solution. 6. When prompted, insert the Treated Water tubing into the Sodium Hypochlorite System Cleaning Solution container 7. In the software, select Continue – the system will cycle for approximately 15 minutes 8. When prompted, remove the tubing out of the Sodium Hypochlorite System Cleaning Solution container 9. Select Continue – the system will cycle for approximately 30 minutes while it flushes the instrument 10.Clean the Treated Water container (refer to Monthly Maintenance activities) and refill with freshly prepared treated water 11.When prompted, insert the tubing into the filled Treated Water container 12.Select Continue – the system will cycle for approximately 15 minutes 13.When prompted, remove the tubing from the Treated Water container 14.Select Continue – the system will cycle for approximately 30 minutes Note: The system will prompt the Operator to repeat steps 11 through 14 three times. Once the process has completed, the system will automatically return to a stand-by state. Perform a Prime System and check the syringes for air bubbles. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. As-Needed Maintenance Replace the Cuvette Rotor From the Home screen select the Tasks icon 1. Select the Maintenance tab 2. Remove the Cuvette Rotor Cover 3. In the software, select Replace Cuvette Rotor 4. Pull up on the Stirrer unit using the Stirrer Knob [1] O 5. Remove the cuvette rotor by pulling up using the Center Knob [2] 6. Install the new cuvette rotor by carefully aligning the O four notches of the new cuvette above the slits on the rotor holder (the cuvette rotor will drop down) 7. Push down the Stirrer Knob 2 8. In the software, select Continue 210 9. Select Yes at the “Reset Cuvette Rotor Counter” prompt 10.Select the Reset icon to reset the system and return to a stand-by state 11.Replace the cuvette rotor cover 12.Perform a cuvette rotor blank  Home screen > Start of Day > Check Cuvette Blank  Select Run > Yes Note: When the cuvette blank is within the defined acceptable ranges, the measurement is automatically accepted and the information on the screen is updated. No further action is required. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. As Needed © Siemens AG 2013. All rights reserved. Maintenance As-Needed Maintenance Fill the Cooling Fluid 1. Remove the Front Panel from the instrument by lifting it up from the bottom and pulling it forward. 2. Check the Cooling Fluid level in the reservoir. The level should be between the minimum [3] and maximum [2] markers. 2 Note: If the cooling fluid level is below the Minimum [3] marker, proceed to step 3. 3. Fill the Cooling Fluid reservoir: 3  Remove the cooling fluid reservoir cap [1]  Add Cooling Fluid until the level is just below the maximum marker [2]  Reattach the cap [1]  Re-install the front instrument panel Note: The Cooling Fluid must be diluted with distilled water. Use 1 part Cooling Fluid to 4 parts distilled water. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. As-Needed Maintenance Clean Reagent Rotor Compartment 1. Cap the reagent bottles that are on the Reagent Rotor 2. Remove the Reagent Rotor with the capped reagent bottles and store appropriately following standard laboratory practices 3. Remove the Reagent Rotor from the system:  Remove the Reagent Rotor cover  Remove the knob from the center of the rotor  Lift the Reagent Rotor out of the instrument 4. Clean the Reagent Rotor:  Pour all condensation fluid out of the rotor  Dry the inside and outside of the rotor with a paper tissue or a clean, dry cloth Dry the Stator (base on which the rotor rests) with 13 5. a paper tissue or a dry, clean cloth 6. Reinstall the Reagent Rotor:  Align the white dot on the rotor with the dot on the driving axle  Reinstall the knob 7. Uncap the reagent bottles 8. Replace the Reagent Rotor cover © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. © Siemens AG 2013. All rights reserved. Backing Up Backing up the System Database From the Home screen select the Tasks icon 1. Select Routine Tasks tab 2. Select Backup and Archive > Backup Now 3. Select Yes at the Perform backup? screen prompt Database Backups File Edit View Favorite's Tools Hri Search Folders Transferring a Backup Database to External Address 3 C:\Documents and Settings\All Users)Application Data)ELITech Clinical Systems)Pro Series Software)Database Backs Nome - Size Type Ote Modified File and Folder Tasks badap_20140501050027 8,065 KB DAT File 5/1/2014 5:00 AM Media Device Rename this file badLo 20140502050095 9.905 KB DAT Fle 5/2/2014 5:00 AM Move this file backup_20140508105159 11, 137 KB DAT Fle 5/8/2014 10:52 AM badkap_20140509050009 11,521 KB DAT Fle 5/9/2014 5:00 AM From the Home screen select the Tasks icon Copy this file bado 20140510050047 0,003 ID DAT Fle S/10/2014 5:00 AM Publish this file to the web bada.p_20140511050055 8,833 KB DAT F'. E-mail this file backup_20140512050004 8,833 KB. DAT F Copy Items X Delete this file Select the place where you want to copy 1. Select Routine Tasks tab backup_20140512050004'. Then click the Copy button. Other Places Desktop 2. Select Backup and Archive > View Pro Series Software My Documents My Documents 8. R. My Computer Backup Files WES (C:) Shared Documents My Computer Shareno 5 3. Select the desired Backup Database to My Network Places USB Video My Network, Places highlight it Details To view any subfolders, click a plus sion above. 4. Select Edit > Copy to Folder Make New Folder Copy Cancel 5. Select Removable Disk (D:) 6 6. Select Copy 7. Select X to close the window 8. Select the green arrow at the bottom right of the screen 9. Select “Safely Remove Hardware… to ZijStart / Pro Series Software Database Backups remove USB © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Backing Up Backing Up Transferring Archive Files to External Media Device From the Home screen select the Tasks icon Tasks 7 Pro Series Software admin 1. Select Routine Tasks tab 014 3:18:19 PM Logout Print Help 2. Select Backup and Archive > View Routine Tasks Maintenance Back - SearchFolders Address |() C:\Documents and Settings\All Users\Application Data)ELITach Clinical Systems'\Pro Series Software Backup Files Backup and Archive File and Folder Tasks Archive Dat 4 Database Backups Export and Import Rename this Folder 3. On the left of the screen, under ‘Other Move this folder Copy this folder Export Data Packaged Diagnostik Logs Places’, select Pro Series Software Publish this folder to the Web E-mall this folder's files System Doka Teno 4. Select the Archive Data Folder X Delete this folder Confirm Folder Replace XJ 5. Select Edit > Copy to Folder Other Places Thes folder already contains a folder named"Archive Data', ELITech Cirical Systems If the files in the exiting folder have the same name as fles in the 6. Select Removable Disk (D:) My Documents folder you are moving or copying, they wil be replaced. Do you stil want to move or copy the folder? Backup Now Shared Documents My Computer Yes Yes to All No Cancel View Backup Files 7. Select Copy My Network. Places 8. Select Yes to All 8 Details 9. Select X to close the window 10. Select the green arrow at the bottom right Explorer Archive All of the screen Close Software Upgrade Archive Filon 11. Select “Safely Remove Hardware…to QC remove USB Bij Start ri- Pro Series Software Pro Series Software © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Troubleshooting Cuvette Blank Not Automatically Accepted Start of Day admin 3/31/2014 8:18:33 AM Logout Print Help 1. From the Home screen, select Start of Day > Description Status Check Cuvette Blank Empty Waste 340 415 505 546 570 600 660 700 2 Fill treated water container Average SD Gain Check syringes Cuvette 0.4069 0.0141 Last Blank 3/28/2014 12:39 PM Check cuvette blank 13 Expiration 3/29/2014 4:39 PM KKK Lamp 1.9649 0.0003 2. Select Edit Check/refill 10% cleaning solution Graph Table 5. 0.06 6. Check daily report 0.04 3. Select the desired cuvette blank measurement, 0.02 then select Disable 0 -0.02 -0.04 Delta from Mean (Abs) 4. Select Accept to accept the remaining cuvette -0.06 3 5 7 9 11 13 5 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 Cuvette blank measurements Selected Cuvette 1 > Cuvette blank is waiting to be accepted. Print Attopt Reject Edit Note: Up to 5 cuvettes can be excluded before the O Qc cuvette rotor must be replaced. Excluded cuvettes will Stop Home Reagents Calibration Contrel Patients Results Unload Events not be used by the system. If an excluded cuvette is selected, selecting Enable reactivates the cuvette for use with the next cuvette blank measurement. © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Troubleshooting © Siemens AG 2013. All rights reserved. Troubleshooting Reagents admin 5/13/2014 9:09:55 AM Logout Print Help Filter by Test Print Reagent Info Pos Insufficient Reagent / Cap Left on Reagent Bottle Tests Reagent Status Load Standard R1 AM5 R1 Switch Rotor R2 C15 R1 Unload R5 5 R4 1. Wait for system to show processing finished status R3 OP3 R1 Replace R4 T50 R1 R5 CR R1 R19 Note: The system will continue to process R3 R6 RI R18 tests that have been started in the cuvette. R7 R21 R8 R17 R2 Reagent arm will move to wash station when R9 R10 R16 complete. R11 R12 Probe rins R13 2. Using the Reagent Rotor display on the Reagents Acid Solution 4 R14 2 R15 screen, identify which reagent is in error by R25 R14 R16 AM5 R17 locating the reagent with the red status C15 R2 R13 R18 OP3 R2 R19 T50 R2 3. Lift up the glass lid and remove the reagent bottle 6 R20 CR R2 cap or fill empty bottle with the same lot of QC reagent. Stop Home Reagents Calibration Control Patients Resume Results Unload Oc Events  Run controls only on the reagent used to fill Results admin ? the bottle 5/14/2014 1:24:09 PM Logout Print Help Reagent Blanks Calibration and Controls Patients Search  If the lot number is different, fill the new Loaded Recent Sample details #1 Repeat -- bottles with reagent, then calibrate and run ID Name Status MR# Sex Male R-: Insufficient Reagent Sample ID 1230 Request Type Routine Attention Required controls 1230 Jane White 7 Patient Name Jane White Sample Type Urine Birth Date Sent to LIS No Physician Status Attention Required 4. On the Reagents screen, select the bottle with the Collection Date Completion red status on the Reagent Rotor display or the Comment reagent list Test Name Value Flags AM5 R-vlc 5. Select Replace > Accept #1 Repeat R- #2 Repeat Negative 0.3517 V  If the reagent is a new lot, enter new lot 6AM Negative 0.4970 v C15 Negative 0.2651 v number and expiration date 6. From the bottom icons, select Results 8 Options View Test View Calibration aw Blank Comment 7. Samples requiring attention will be indicated by an Summary Report Print Resend to LIS Export Repeat 9 Accept Reject Cancel Test orange flag. Qc 8. Select the sample and test with the insufficient Stop Home Reagents Calibration Control Patients Results Unload oc Events reagent then select Repeat © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. 9. Select Resume © Siemens AG 2013. All rights reserved. Troubleshooting Configure admin 7/8/2014 8:59:12 AM Logout Print Help Tests System Edit / New Lot Button not Available Tests Control Level 5 (Positive Edit Lot New Lot Calculated Test Lot F5 Expiration 8/31/2015 1. Is the glass safety cover down? Panels Test Rule Type Expiration Separation Target Low High Calibrators  Close the cover Amphetamines 500, Separation 10.045 Controls Cocaine 150 Separatio 1d Calibrator Lot Opiates 300 Seporatio 10.064 2. Are there patient requests? Control Lot THC 50 Separtition Probe Incompatibilities  Delete requests Test Incompatibilities Test Order 3. Are there calibration and/or control requests? Accept  Cancel calibration requests O QC  Cancel control requests Stop Home Reagents Calibration Control Patients Results Unload Qc Events 4. Remove the reagents off the rotor. Reagents admin ?  Select Reagents 7/7/2014 4:10:36 PM Lopeut Print Help Filter by Test Print Reagent Into  Select Switch Rotor Pos Tests Reagent Status Lood Standard  Select Auxiliary AMS Switch Rotor R2 C15 RS R3 T50 RA RA OP3 R5 R3 2 2 2 2 2 R7 Switch rotor RS Switching rotor will unload the currently loaded bottles and automatically reload the bottles that were last loaded on the selected rotor. R2 Any test results requiring the currently loaded bottles may be affected. R11 R12 Probe rinse Standard Auxiliary Maintenance Cancel R1 R13 Acid Solution R14 R15 AMS R17 C15 R2 R18 150 R19 OP3 R2 R20 GR Stop Nome Heagents Calibration Control Process Results Upload © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials. © 2016 Siemens Healthcare Diagnostics Inc. All rights reserved. This guide and the software described within, are copyrighted. No part of this may be copied, reproduced, translated, or reduced to any electronic medium or machine-readable form without the prior written consent of Siemens Healthcare Diagnostics. SYVA, VIVA PROE and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or it affiliates. All other trademarks are the property of their respective owners. HILS#705 Effective date: 06/01/16 Note: This document is for supplemental use only and is not intended to be used in place of primary technical materials. Global Siemens Headquarters Global Siemens Healthcare Headquarters Global Division Siemens AG Siemens AG Siemens Healthcare Diagnostics Inc. Wittelsbacherplatz 2 Healthcare Sector 511 Benedict Avenue 80333 Muenchen Henkestrasse 127 Tarrytown, NY 10591-5005 Germany 91052 Erlangen USA Germany www.siemens.com/diagnostics © Siemens Healthcare Diagnostics Inc. 2016 All rights reserved. www.siemens.com/diagnostics